| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y and W) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Invasive meningococcal disease (IMD) |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10027274 |
| E.1.2 | Term | Meningococcal infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW conjugate vaccine in subjects who were first vaccinated with 1 dose of MenACYW conjugate vaccine or Menveo vaccine 3-6 years before the booster dose (Groups 1 and 2) |
|
| E.2.2 | Secondary objectives of the trial |
To describe:
-vac seroresponse, seroprotection: serum bactericidal assay using human complement [hSBA] titer ≥1:8 and Ab responses [GMTs] of meningococcal serogroups ACYW measured using hSBA in serum specimens collected 6 d ±1 after vaccination in a subset of 50 subj per gr(1,2)
-vac serorespns, seroprotct and Ab resp to serogrp ACYW on D0 pre-vacc and D30 +14d after vacc with MenACYW conju vac alone (1,2)
-Ab persistence of meningococcal serogrp ACYW before a booster dose in subj who received either MenACYW conju vac or Menveo vac 3-6 y earlier
-Ab persistence of meningococcal serogrp ACYW in subj who received either a single dose MenACYW conju vac subj rdmzd to MET59 Gr1,3,4 or Menveo vac: subj assigned to MET59 Gr 2 as part of MET50 or MET43: subj randomized to MET59 Gr1,3 and 4
-vac seroresponse, seroprotection and Ab responses to the Ag present in MenACYW conju vac, when MenACYW conju vac is given concomitantly with MenB vac(3,4) compared to those when it is given alone (1) |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Aged ≥ 13 to < 26 years on the day of inclusion
- Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only)
- For Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants have a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion
- Participants aged 13 to < 18 years: assent form has been signed and dated by the participant and informed consent form (ICF) has been signed and dated by the parent or guardian
- Participants aged ≥ 18 (or legal age of majority, if different from 18 years of age) to < 26 years: ICF has been signed and dated by the participants
- Participant aged 13 to < 18 years: both the participant and parent or guardian are able to attend all scheduled visits and to comply with all trial procedures
- Participants aged ≥ 18 (or legal age of majority, if different from 18 years of age) to < 26 years: able to attend all scheduled visits and to comply with all trial procedures |
|
| E.4 | Principal exclusion criteria |
- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
- Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Visit 3 except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43
- Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Personal history of Guillain-Barré syndrome (GBS)
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Current alcohol abuse or drug addiction
- Chronic illness (eg, HIV, hepatitis B, hepatitis C) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers equal or greater than (≥) 1:16 for participants with pre-vaccination titers lower than (<) 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Day 30 (post-vaccination) |
|
| E.5.2 | Secondary end point(s) |
1 - Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
2 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
3 - Geometric Mean Titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
4 - Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
5 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
6 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W: Group 1 and Group 2 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
7 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
8 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
9 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
10 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA
11 - Percentage of participants achieving seroresponse for meningococcal serogroups A, C, Y and W: Group 1, Group 3 and Group 4 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroresponse is defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:8, or at least a 4-fold increase in post-vaccination titers for participants with pre-vaccination titers ≥ 1:8
12 - Percentage of participants achieving seroprotection for meningococcal serogroups A, C, Y and W: Group 1, Group 3 and Group 4 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA Seroprotection is defined as post-vaccination titers ≥ 1:8
13 - GMTs of antibodies against meningococcal serogroups A, C, Y, and W: Group 1, Group 3 and Group 4 ; Antibody titers against meningococcal serogroups A, C, Y, and W will be measured by hSBA |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3: Day 6 (post-vaccination)
4, 5, 6, 9, 10, 11, 12, 13: Day 0 (pre-vaccination) and Day 30 (postvaccination)
7, 8: Day 0 (pre-vaccination) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
| E.8.4 | Will this trial be conducted at multiple sites globally? | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Day 180 safety follow-up telephone call (approximately 6 months after vaccination). |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 8 |
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